| Primary Device ID | 00057475696009 |
| NIH Device Record Key | b1aa5c67-9d23-48be-8ddb-23a356639030 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOS Professional |
| Version Model Number | FS600 |
| Company DUNS | 246883458 |
| Company Name | Thermor Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00057475696009 [Primary] |
| GS1 | 10057475696006 [Package] Package: Case [40 Units] In Commercial Distribution |
| QKR | Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-28 |
| Device Publish Date | 2023-09-20 |
| 20057475032504 - BIOS Diagnostics | 2026-01-27 Blood Pressure Monitor | Wrist |
| 00057475242909 - BIOS Diagnostics | 2026-01-27 Blood Pressure Monitor, Easy-to-Read |
| 10057475491502 - BIOS Diagnostics | 2026-01-27 Nasal Aspirator |
| 00057475820213 - BIOS Living | 2026-01-27 Onyx Rollator |
| 20057475260945 - BIOS Living | 2024-08-27 Cast Protector, Hand |
| 20057475260952 - BIOS Living | 2024-08-27 Cast Protector, Foot |
| 20057475260976 - BIOS Living | 2024-08-27 Cast Protector, Long Arm |
| 20057475260990 - BIOS Living | 2024-08-27 Cast Protector, Long Leg |